National Institute of Standards and Technology
Medical Device Communication

ICSGenerator



The ISO/IEEE 11073 Standard is a family of documents that defines the entire seven layer communications requirements for the "Medical Information Bus" (MIB). The objective of this standard is to standardize data communications for patient connected bedside devices, optimized for the acute care setting, to allow clinicians to set up device communications in a "plug and play" fashion.

NIST is collaborating with the ISO/IEEE Medical Device Communications working group in developing tools to aid in testing implementations against the ISO/IEEE 11073 set of standards.

The ICSGenerator tool captures the relationships among the managed objects and the data necessary to generate Implementation Conformance Statements (ICSs). The ICS captures details of a specific implementation and specifies which features are implemented.

The ICSGenerator tool processes an xml instance of the ISO/IEEE 11073 Data Information Model (DIM) that contains all the managed objects, their relationships and the information associated to each of them. It provides the capabilities of adding, removing and updating managed objects including its attributes, behaviour and notification. Based on this information the tool generates an XML file representing the containment tree that describes the medical device as specified by the implementer. The XML file contains the data required to generate Implementation Conformance Statement (ICS) reports and any other reports related to the information model or the implementation containment tree. The tool could be utilized as a test identification mechanism for the ISO/IEEE 11073 implementation testing.

image of ICSGenerator work flow

Figure 1. Overview of ICSGenerator Process

ValidatePDU Tool

NIST/ITL is collaborating with the ISO/IEEE 11073 Medical Device Communications working group in developing developing conformance tests and associated tools to provide the medical device industry with the necessary tools to ensure that critical devices properly implement the medical device standards. As part of this effort NIST has developed a tool called ValidatePDU, to validate the basic syntax and structure of messages.

image of ValidatePDU Process

Figure 1. ValidatePDU Process

Figure 1 above shows the process used by the ValidatePDU tool. Step one was to convert the Abstract Syntax Notation(ASN.1) from the ISO/IEEE 11073 standards into schema definitions. The schema definitions are then used to validate XML wrapped messages passed between manager and agent medical devices. The ValidatePDU tool will report such things as incorrect syntax and data type errors. The ValidatePDU tool is a work-in-progress and suggestions and comments about the tool are welcome.